NCT06748287

A Clinical Comparison of FDA-Cleared Photobiomodulation Devices for the Treatment of Alopecia

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Photobiomodulation is a form of non-ionizing light therapy has been shown to stimulate cellular processes and reduce inflammation as well as improve pain and wound healing. Photobiomodulation has also been found to enhance fibroblast growth factor production. A challenge in clinic is to answer the patients' questions regarding which FDA-cleared device is the best to purchase. Therefore, this study was designed to gain experience with the use of the following devices and to clinically evaluate their efficacy: iGrow Hair Growth System, Capillus352, Hair Max Ultima 12 LaserComb, and HairMax Laserband 82. The purpose of this pilot research study is to clinically compare and evaluate FDA-cleared photobiomodulation devices after four months of treatment and one-month follow-up in subjects with alopecia.

Conditions

• Alopecia

Interventions

Type	Name	Description
DEVICE	iGrow Hair Growth System	has a helmet-design and headphones to allow for hands-free use and music listening capabilities. Treatment is 25 minutes every other day. three to four times per week for 4 months.
DEVICE	Capillus352	has a similar design to a salon hair dryer which hovers over the head to allow for hand-free use. Treatment is 12 minutes, three times per week for 4 months.
DEVICE	HairMax Ultima 12 Lasercomb	is comb-like device with hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 8 minutes three times per week for 4 months.
DEVICE	HairMax Laserband 82	is headband design device which has unique hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 90-second treatments three times per week for 4 months.

Timeline

• Start date: 2017-01-03
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study